(11 days)
The Signature Edition Infusion System (infusion pumps and administration sets) is intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.
The Signature Edition Infusion System is indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.
This device is essentially the same as the originally submitted devices (the predicate devices), filed as Models EZ 1 and EZ 2 Infusion Pumps (K931549) and EZ Administration Set Series (K931550). The electrical volumetric pumps and administration sets are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. In general, infusion systems are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid delivery, infusion systems have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.
This document (K032147) is a 510(k) premarket notification for the "Signature Edition Infusion System," which is essentially the same as predicate devices (EZ 1 and EZ 2 Infusion Pumps and EZ Administration Sets) with minor changes. The submission primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a study of its own performance against pre-defined acceptance criteria.
Therefore, the requested information regarding acceptance criteria and performance data for a new study validating the device's performance is not available within this document. The document explicitly states: "The changes as described in this Special 510(k) pose no new issues of safety or efficacy." This implies that extensive new performance studies (especially those with detailed acceptance criteria, expert adjudication, MRMC studies, or standalone performance data) were not deemed necessary because the device is substantially equivalent to already approved devices.
Here's an explanation based on the provided text, acknowledging the lack of specific performance study details:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document asserts that the "Signature Edition Infusion System is essentially the same as the predicate devices," (EZ 1 and EZ 2 Infusion Pumps, K931549, and EZ Administration Sets, K931550). The implication is that the performance of the Signature Edition Infusion System would meet the same performance metrics and acceptance criteria as its predicate devices, but these specific metrics are not detailed in this 510(k) summary. The document states: "The results of this comparison demonstrate that the Signature Edition Infusion System is equivalent in technological characteristics and the fundamental scientific technology of the predicate devices has not been altered." This suggests that previous studies for the predicate devices established their performance, and this current submission relies on that equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. Since this is a 510(k) for substantial equivalence to predicate devices with "no new issues of safety or efficacy," extensive new performance testing with specific sample sizes might not have been required or documented here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the device is an infusion system, not an AI-assisted diagnostic tool. No MRMC study was mentioned or implied.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is an infusion system, not an algorithm. Standalone performance for its intended function (fluid and medication delivery) would be evaluated based on flow rate accuracy, pressure limits, safety features, etc., but specific studies demonstrating this are not detailed in this summary. The fundamental scientific technology has not been altered, implying prior validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided in the document for new testing of this specific device. For the predicate devices, "ground truth" would likely refer to established engineering and physiological standards for infusion accuracy, safety alarms, material compatibility, and reliable fluid delivery, as demonstrated in their original submissions.
8. The sample size for the training set:
This information is not provided in the document. This is not an AI/algorithm-based device that would typically have a "training set."
9. How the ground truth for the training set was established:
This information is not provided in the document. As stated above, this is not an AI/algorithm-based device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).